Everything under control

Erbitux®, which is used to treat colorectal cancer and cancer of the head and neck, is marketed by Merck outside of North America. The aqueous solution contains the active ingredient cetuximab, which detects tumor cells in a targeted manner, attaches itself to the surfaces of the cells and thereby initiates the process of eradicating them. This protein, a monoclonal antibody, is derived from a single mother cell by means of biotechnological processes. This is why Erbitux® is a “living” and thus sensitive substance that requires special care. Fluctuating ambient conditions have an adverse effect on proteins, so they must be processed, stored, and transported at constant temperatures and humidity levels.

Changes to the nutrient solution, the pH, or temperature can diminish the quality and yield of the active ingredient cetuximab already during the production stage. A single bacterial contamination in the bioreactor would even ruin the entire production batch, which is why the entire process is strictly regulated.

The aqueous solution Erbitux® is filled into sterile glass vials in 20-, 50-, or 100-milliliter sizes. The vial openings are closed with plastic stoppers and mechanically protected with a cap. Before leaving the point of production, the vials undergo a visual inspection. In this step, Merck employees check to ensure that the liquid isn’t contaminated by foreign substances such as hairs or plastic splinters.

Only a qualified person is permitted to release the product for shipping. This specially qualified person is responsible for compliance with all regulations governing drugs, and the tasks they must perform are specified in the relevant drug law. A particularly important part of their job is to see to it that the individual drug batches correspond to the registration regulations of the various countries to which the drugs are shipped. Have all previous steps in the process been carried out correctly to this point? Do the packages contain the right usage instructions? And are the medications being shipped by an authorized manufacturer? The qualified person must check and confirm that all these questions are answered in the affirmative before Merck is allowed to release the drug for transport. While it is true that the qualified persons are Merck employees and are paid by the company, they also are personally responsible for the inspections they perform, as required by law, in order to prevent conflicts of interest.

Ensuring that the “living” pharmaceutical products with its protein content isn’t damaged requires Erbitux® to be strictly maintained at temperatures between two and eight degrees on its way to the patient. The refrigerated warehouses operated by Merck for temporary storage of the drugs therefore meet the highest standards. Emergency power generators, for example, ensure that refrigeration is uninterrupted in the event of a power outage. What’s more the buildings are built and insulated in a manner that guarantees the temperature will remain constant for at least two hours even if the refrigeration systems aren’t running. And all responsible staff, from the shift supervisor to the building superintendent from facility management to the plant fire department, are prepared around the clock to rapidly eliminate malfunctions or interruptions.